About this trial
The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients undergoing elective robot assisted hiatal hernia repair
Disqualifiers
patients less than 18 years of age
conversion to open surgery
BMI > 40
history of abdominoplasty
Trial design
Parallel
Treatments tested in this trial
Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Procedure/SurgeryElective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Procedure/SurgeryElective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Treatment groups
Trial outcomes
Primary outcomes
Reduction in post-operative shoulder pain
Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment
Secondary outcomes
Severity of postoperative shoulder pain on POD #0
Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \~7PM)
Severity of postoperative shoulder pain on POD #1
Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \~6-8AM)
Severity of postoperative shoulder pain at ~1 week
Severity of postoperative shoulder pain at \~1 week post-operative telephone appointment
Severity of postoperative shoulder pain at ~2 weeks post-op
Severity of postoperative shoulder pain at \~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: